Apparatus for the treatment of female sexual dysfunction

ABSTRACT

There is disclosed an apparatus for treating a sexual dysfunctional female patient, comprising an implanted stimulation device adapted to stimulate at least a part of the vagina of the patient by movement of said stimulation device and contact between said stimulation device and the sexually responsive tissue or the wall of the vagina. A system and an operation method for the treatment of female sexual dysfunction are also disclosed.

This application is a continuation of U.S. patent application Ser. No.14/827,560, filed Aug. 17, 2015, and issued as U.S. Pat. No. 9,629,775which is a continuation of U.S. patent application Ser. No. 14/094,402,filed Dec. 2, 2013, and issued as U.S. Pat. No. 9,107,796, which is acontinuation of U.S. patent application Ser. No. 13/122,907, filed Apr.6, 2011, and issued as U.S. Pat. No. 8,600,510, which is the U.S.National Phase of International Application No. PCT/SE2009/051128, filed9 Oct. 2009, which designated the U.S. and claims the priority fromSwedish Application No. 0802151-1, filed Oct. 10, 2008, and claims thebenefit of U.S. Provisional Application No. 61/227,812, filed on 23 Jul.2009, the entire contents of each of which are hereby incorporated byreference in this application.

TECHNICAL FIELD

The present invention relates to the treatment of female sexualdysfunction

BACKGROUND

A lot of attention has been given to male sexual disorders includingimpotency. This has lead to the availability of a number of treatmentoptions for males, including pharmaceuticals such as Viagra.

In contrast, there is a lack of therapies for treating female sexualdysfunction. Female sexual dysfunction such as disorders of sexualdesire, arousal or orgasm is a common problem, affecting up to 43% ofall women (Pauls et al, Obstret Gynecol Surv, 2005 60(3):3196-205). Bothbiological and psychological factors contribute to FSD.

Available treatments include psychological counselling to pairs orindividuals. Where side effects of medication contributes to FSD,altering medication or dosage may help. However, there is a need forimproved treatment of FSD.

During sexual arousal of the female, vasocongestion of the pelvic regionleads to engorgement of the genitalia with blood leading to swelling ofthe external genitalia and erection of the clitoris. This is accompaniedby lubrication of the vagina. In the female, the corpus cavernosa aretwo paired symmetrical extensions of the clitoris and engorgement ofthese is an important step during sexual arousal of the female.

Female sexual arousal is enhanced by stimulation of the vulva, such astouching or caressing the clitoris.

Hand held or other external devices that stimulate the clitoris arewell-known. For example U.S. Pat. No. 7,081,087B2 discloses a sexual aidthat vibrates. There has been proposed a device for treating FSD thatapplies a vacuum or suction to the clitoris. This will create a negativepressure that promotes the engorgement of the clitoris with blood(Hovland Claire, U.S. Pat. No. 6,464,653B1).

The local administration of prostaglandins to the female genetalia inorder to treat FSD has been described in U.S. Pat. No. 6,486,207.

The implantation of an electrode that stimulates the peripheral nervesof the vulva has been described (US 2008/0103544).

SUMMARY OF THE INVENTION

It is an object of the present invention to obviate at least some of thedisadvantages in the prior art and provide a new strategy for treatingfemale sexual dysfunction by positively affecting sexual stimuli andorgasm.

One characteristic of the invention is to enable the patient to enhancethe patient's own response to sexual stimuli from the partner.

One advantage is that the likelihood to get orgasm will increase by thestimulation device.

Another advantage is that the sexual response to sexual stimuli willincrease.

The proposed device is implanted. An advantage with the implantation ofa stimulating device is that it is always at hand and can convenientlybe switched on before sexual intercourse. Hand held devices are morelikely to cause embarrassment.

In a first aspect there is provided an apparatus for treating a sexualdysfunctional female patient, comprising an implanted at least onestimulation device adapted to stimulate at least a part of the sexuallyresponsive tissue of the vulva or the wall of the vagina of the patientby movement of said stimulation device and contact between saidstimulation device and at least one area of the sexually responsivetissue or the wall of the vagina.

In a second aspect there is provided at least one operation deviceadapted to operate said at least one stimulation device. The operationdevice may be an integrated part of the stimulation device or thestimulation and operation device may be the same and one unit. The atleast one operation device may be also implanted at a distance from theat least one stimulating device.

Further embodiments comprise that the at least one stimulating device isadapted to be implanted in the region of the sexually responsive tissueof the vulva or the wall of the vagina, wherein the at least onestimulating device is adapted to create movement preferable with afrequency from 0.1 to 10,000 Hz, and wherein the at least onestimulating device is adapted to create movement preferable with anamplitude of from 0.01 to 30 mm.

The apparatus may further comprise a control device for manuallycontrolling the at least one stimulating device from outside thepatients body, and may further comprise a control device for controllingthe intensity of the stimulation device.

Alternatively the apparatus may comprise a control device and at leastone sensor adapted to detect a physiological parameter of the patientand/or a functional parameter of the apparatus, wherein said controldevice comprises a control unit adapted to automatically control the atleast one stimulating device based on input from said at least onesensor.

The operation device may comprise many different embodiments such as; anelectromagnetic device, wherein the movement is achieved by saidelectromagnetic device, an electric motor, wherein the movement isachieved by said electric motor, a hydraulic device, wherein themovement is achieved by said hydraulic device, a mechanical device,wherein the movement is achieved by said mechanical device, a motor,wherein the movement is achieved by said motor.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe apparatus

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the apparatus.

In a preferred embodiment, the system comprises a hydraulic operationdevice for operating the apparatus.

In one embodiment, the system comprises comprising a motor or a pump foroperating the apparatus.

There are also included a method operating and using said stimulationdevice. In a first aspect there is provided an operation method usingthe apparatus comprising the steps of: creating an opening in the skinor vaginal wall of the female patient, dissecting an one area of thesexually responsive tissue, placing the stimulation device within saidarea, adapted to postoperatively stimulate said sexually responsivetissue on patient command.

Further steps may include placing an operation device and a power sourcewithin the body.

The step of placing a stimulation device may comprise placing anintegrated unit comprising the stimulation device and an operationdevice in the same integrated unit.

The step of placing a power source may comprise placing a control unitand a rechargeable battery remote from said sexually responsive tissue.

The operation method preferable includes controlling said stimulationdevice post-operatively and non-invasively from outside the body.

In a second aspect there is provided a laparoscopic operation method,wherein the step of creating an opening in the skin or vaginal wall ofthe female patient comprising: inserting a tube or needle into thepatients body, filling the tube or needle with a gas and therebyexpanding a cavity within the female patients body, inserting at leasttwo laparoscopic trocars into said cavity, inserting at least one cameratrough at least one laparoscopic trocar, inserting at least onedissecting tool through at least one laparoscopic trocar,

Further aspects and embodiments are defined in the appended claims,which are specifically incorporated herein by reference.

Definitions

Before the invention is disclosed and described in detail, it is to beunderstood that this invention is not limited to particular surgicalsteps, configurations, method steps, substrates, and materials disclosedherein as such surgical steps, configurations, method steps, substrates,and materials may vary somewhat. It is also to be understood that theterminology employed herein is used for the purpose of describingparticular embodiments only and is not intended to be limiting since thescope of the present invention is limited only by the appended claimsand equivalents thereof.

It must be noted that, as used in this specification and the appendedclaims, the singular forms “a”, “an” and “the” include plural referentsunless the context clearly dictates otherwise.

If nothing else is defined, any terms and scientific terminology usedherein are intended to have the meanings commonly understood by those ofskill in the art to which this invention pertains.

The term “about” as used in connection with a numerical value throughoutthe description and the claims denotes an interval of accuracy, familiarand acceptable to a person skilled in the art. Said interval is ±10%.

The term “contact” refers to: union or junction of surfaces, includingbut not limited to: touching, contact, stroking and poking.

The term “movement” refers to: changing of place or position or posture,including but not limited to:

vibration, oscillation, kneading, rotation, alternating expansion andcontraction.

The term “Sexually responsive tissue of the vulva” refers to: theclitoris, labia minor, labia major, the corpora cavernosa and thevestibule.

The term “in the region of” refers to: in or close to.

The term “female erectile tissue” as used throughout the description andthe claims denotes i) tissue of the female sexual organs that before orduring sexual intercourse are filled with blood including the corporacavernosa of the clitoris and the vestibular bulbs, ii) extensions ofsaid tissue, including blood vessels and the surrounding tissues.

DETAILED DESCRIPTION OF THE INVENTION

In a first aspect there is provided an apparatus for treating a sexualdysfunctional female patient, comprising an implanted at least onestimulation device adapted to stimulate at least a part of the sexuallyresponsive tissue of the vulva or the wall of the vagina of the patientby movement of said stimulation device and contact between saidstimulation device and at least one area of the sexually responsivetissue.

In various embodiments the apparatus stimulates selected parts of thefemale genitalia. Thus in one embodiment the apparatus stimulates thesexually responsive tissue of the vulva.

In one embodiment the apparatus stimulates the wall of the vagina.

In one embodiment the apparatus stimulates one or more of the clitoris,the labia major, the labia minor, the vestibule and the corporacavernosa.

In a main embodiment there is provided an apparatus comprising at leastone operation device adapted to operate said at least one stimulationdevice, where the at least one stimulating device is adapted to beimplanted in the region of the sexually responsive tissue of the vulvaor the wall of the vagina. The stimulating device is adapted to movewith a frequency from 0.1 to 10,000 Hz and with an amplitude of from0.01 to 30 mm. In one embodiment the at least one stimulating device isadapted to create movements along more than one axis.

In one embodiment the invention further comprises a control device formanually controlling the at least one stimulating device from outsidethe patients body. The control device controls the intensity of movementof the stimulation device. The control device may independently controlamplitude and frequency of the movement in the two different axes.

In another embodiment the apparatus comprises a control device and atleast one sensor adapted to detect a physiological parameter of thepatient and/or a functional parameter of the apparatus, wherein saidcontrol device comprises a control unit adapted to automatically controlthe at least one stimulating device based on input from said at leastone sensor.

In another embodiment the at least one stimulating device is controlledby an endogenous signal.

In one embodiment the at least one operation device is adapted to beimplanted at a distance from the at least one stimulating device.

In one embodiment there are at least two stimulating devices, adapted tobe placed in the region of the sexually responsive tissue of the vulvaor the wall of the vagina.

In one embodiment the operation device is an integrated part of thestimulation device or the stimulation device and operation device arethe same and one unit.

The movement may be achieved by different means in differentembodiments. Thus, operation device may comprise an electric motor, ahydraulic device, a mechanical device, or a magnetic device. Themovement may also be achieved by a piezoelectric element, an eccentricmechanism, or an electromagnetic mechanism.

In one embodiment, the apparatus comprises at least one expandableprostheses adapted for implantation in female erectile tissue andadapted to be adjusted to temporarily achieve enlarged status of thefemale erectile tissue. The prostheses may be controlled and energizedby the system in the same manner as the stimulation device.

In one embodiment the apparatus comprises at least one implantablereservoir, adapted to be implanted in the sexually responsive tissue ofthe vulva of the patient, wherein said at least one stimulation deviceis placed in said at least one reservoir.

In one embodiment, the stimulation device is adapted to be implanted inthe region of the clitoris of the female patient.

In a second aspect there is provided a surgery method where an apparatusas described above is implanted in the patient.

A third aspect there is provided a system that comprises an apparatus asdescribed above.

In one embodiment the system comprises at least one switch implantablein the patient for manually and non-invasively controlling theapparatus.

In one embodiment the system comprises a hydraulic device having animplantable hydraulic reservoir, which is hydraulically connected to theapparatus, wherein the apparatus is adapted to be non-invasivelyregulated by manually pressing the hydraulic reservoir.

In one embodiment the system comprises a wireless remote control fornon-invasively controlling the apparatus. The wireless remote controlmay comprise at least one external signal transmitter and/or receiver,further comprising an internal signal receiver and/or transmitterimplantable in the patient for receiving signals transmitted by theexternal signal transmitter or transmitting signals to the externalsignal receiver.

In one embodiment the wireless remote control transmits at least onewireless control signal for controlling the apparatus. The controlsignal may be different in different embodiments, for example anelectric field, a magnetic field, or a combined electric and magneticfield In one embodiment the wireless control signal comprises afrequency, amplitude, or phase modulated signal or a combinationthereof.

In one embodiment the wireless remote control transmits anelectromagnetic carrier wave signal for carrying the control signal.

One embodiment comprises a wireless energy-transmission device fornon-invasively energizing implantable energy consuming components of theapparatus or the system with wireless energy.

The wireless energy may comprise wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. The signal may be an analogue signal, a digitalsignal, or a combination of an analogue and digital signal

The wireless energy may be different in different embodiments, forexample: an electric field, a magnetic field, or a combined electric andmagnetic field.

In a main embodiment there is provided an implantable internal energysource for powering implantable energy consuming components of theapparatus.

In one embodiment there is provided an external energy source fortransferring energy in a wireless mode, wherein the internal energysource is chargeable by the energy transferred in the wireless mode.

In one embodiment there is provided a sensor or measuring device sensingor measuring a functional parameter correlated to the transfer of energyfor charging the internal energy source, and a feedback device forsending feedback information from inside the patient's body to theoutside thereof, the feedback information being related to thefunctional parameter sensed by the sensor or measured by the measuringdevice.

One main embodiment further comprises a feedback device for sendingfeedback information from inside the patient's body to the outsidethereof, the feedback information being related to at least one of aphysiological parameter of the patient and a functional parameterrelated to the apparatus.

In one embodiment there is provided a sensor and/or a measuring deviceand an implantable internal control unit for controlling the apparatusin response to information being related to at least one of aphysiological parameter of the patient sensed by the sensor or measuredby the measuring device and a functional parameter related to theapparatus sensed by the sensor or measured by the measuring device. Thephysiological parameter may be a pressure or a motility movement.

In one embodiment there is provided an external data communicator and animplantable internal data communicator communicating with the externaldata communicator, wherein the internal communicator feeds data relatedto the apparatus or the patient to the external data communicator and/orthe external data communicator feeds data to the internal datacommunicator.

In one embodiment there is provided a motor or a pump for operating theapparatus.

In one embodiment there is provided a hydraulic operation device foroperating the apparatus.

In one embodiment there is provided an operation device for operatingthe apparatus, wherein the operation device comprises a servo designedto decrease the force needed for the operation device to operate theapparatus instead the operation device acting a longer way, increasingthe time for a determined action.

In one embodiment there is provided an operation device for operatingthe apparatus, wherein the wireless energy is used in its wireless stateto directly power the operation device to create kinetic energy for theoperation of the apparatus, as the wireless energy is being transmittedby the energy-transmission device.

In one embodiment there is provided an energy-transforming device fortransforming the wireless energy transmitted by the energy-transmissiondevice from a first form into a second form energy.

In one embodiment the energy-transforming device directly powersimplantable energy consuming components of the apparatus with the secondform energy, as the energy-transforming device transforms the first formenergy transmitted by the energy-transmission device into the secondform energy.

In one embodiment the second form energy comprises at least one of adirect current, pulsating direct current and an alternating current.

In one embodiment there is provided an implantable accumulator, whereinthe second form energy is used at least partly to charge theaccumulator.

In one embodiment the energy of the first or second form comprises atleast one of magnetic energy, kinetic energy, sound energy, chemicalenergy, radiant energy, electromagnetic energy, photo energy, nuclearenergy thermal energy, non-magnetic energy, non-kinetic energy,non-chemical energy, non-sonic energy, non-nuclear energy andnon-thermal energy.

In one embodiment there are provided implantable electrical componentsincluding at least one voltage level guard and/or at least one constantcurrent guard.

In one embodiment there is provided a control device for controlling thetransmission of wireless energy from the energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto, the system furthercomprising a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

In one embodiment the determination device is adapted to detect a changein the energy balance, and the control device controls the transmissionof wireless energy based on the detected energy balance change.

In one embodiment the determination device is adapted to detect adifference between energy received by the internal energy receiver andenergy used for the implantable energy consuming components of theapparatus, and the control device controls the transmission of wirelessenergy based on the detected energy difference.

In one embodiment the energy-transmission device comprises a coil placedexternally to the human body, further comprising an implantable energyreceiver to be placed internally in the human body and an electriccircuit connected to power the external coil with electrical pulses totransmit the wireless energy, the electrical pulses having leading andtrailing edges, the electric circuit adapted to vary first timeintervals between successive leading and trailing edges and/or secondtime intervals between successive trailing and leading edges of theelectrical pulses to vary the power of the transmitted wireless energy,the energy receiver receiving the transmitted wireless energy having avaried power.

In one embodiment the electric circuit is adapted to deliver theelectrical pulses to remain unchanged except varying the first and/orsecond time intervals.

In one embodiment the electric circuit has a time constant and isadapted to vary the first and second time intervals only in the range ofthe first time constant, so that when the lengths of the first and/orsecond time intervals are varied, the transmitted power over the coil isvaried.

In one embodiment there is provided a system comprising an implantableinternal energy receiver for receiving wireless energy, the energyreceiver having an internal first coil and a first electronic circuitconnected to the first coil, and an external energy transmitter fortransmitting wireless energy, the energy transmitter having an externalsecond coil and a second electronic circuit connected to the secondcoil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.

In one embodiment there is a an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil, wherein the external second coilof the energy transmitter transmits wireless energy which is received bythe first coil of the energy receiver, the system further comprising afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorsbetween the first and second coils.

In one embodiment the transmitted energy may be regulated depending onthe obtained coupling factor.

In one embodiment there is provided a system wherein the external secondcoil is adapted to be moved in relation to the internal first coil toestablish the optimal placement of the second coil, in which thecoupling factor is maximized.

In one embodiment there is provided a system wherein the external secondcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

In a third aspect there is provided an operation method using anapparatus or system according to the above further comprising the stepsof: a) creating an opening in the skin or vaginal wall of the femalepatient, b) dissecting an one area of the sexually responsive tissue, c)placing the stimulation device within said area, adapted topostoperatively stimulate said sexually responsive tissue on patientcommand.

In one embodiment there is provided an operation method comprising thestep of placing an operation device and a power source within the body.

In one embodiment the operation method comprises placing a stimulationdevice comprising placing an integrated unit comprising the stimulationdevice and an operation device in the same integrated unit.

In one embodiment the operation method comprises placing a power sourcecomprising, placing a control unit and a rechargeable battery remotefrom said sexually responsive tissue.

In one embodiment the operation method comprises controlling saidstimulation device post-operatively and non-invasively from outside thebody.

In one embodiment the operation method comprises the step of creating anopening in the skin or vaginal wall of the female patient comprising, a)inserting a tube or needle into the patients body, b) filling the tubeor needle with a gas and thereby expanding a cavity within the femalepatients body, c) inserting at least two laparoscopic trocars into saidcavity, d) inserting at least one camera trough at least onelaparoscopic trocar, e) inserting at least one dissecting tool throughat least one laparoscopic trocar,

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,in which:

FIG. 1a-g illustrates an apparatus and a system for treating femalesexual dysfunction, wherein the system includes an apparatus of theinvention implanted in a patient.

FIGS. 2-16 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 1.

FIG. 17 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 1.

FIG. 18 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 19 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 1.

FIG. 20 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

FIGS. 21-27C show various ways of arranging hydraulic or pneumaticpowering of an apparatus implanted in a patient.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1a illustrates a system 300 for treating a female patient sufferingfrom FSD comprising an apparatus 10, comprising two stimulation devices201, of the present invention placed in the abdomen of a patient. Animplanted operation device 302 is adapted to supply energy consumingcomponents of the apparatus with energy via a power supply line 303.

FIG. 1b shows the apparatus 10 and system 300 in more detail. Theapparatus 10 comprises two stimulation devices 201. The apparatus 10 isimplanted and in contact with the sexually responsive tissue of thevulva 205 of the patient. An implanted operation device 302 is adaptedto supply energy consuming components of the apparatus with energy via apower supply line 303.

An external energy-transmission device 304 for non-invasively energizingthe apparatus 10 transmits energy by at least one wireless energysignal. The implanted energy-transforming device 398 transforms energyfrom the wireless energy signal into electric energy which is suppliedvia the power supply line 303.

The system 300 can be controlled with a remote control 396. Also asubcutaneous control switch 306 can be used to control the apparatus. Inone embodiment a sensor 202 measures at least one physiological orfunctional parameter. The location of the sensor 202 is adapted to thecircumstances, e.g. which parameter that should be measured. The sensor202 may e.g. be connected to the energy-transforming device 398 or thecontrol unit 315 via a communication line 1072 that also may supplypower to the sensor 202.

The operation device 302 may comprise at least one item selected fromthe group consisting of; a control unit 315, a battery 322, a sensor325, a motor 307, a pump 309, a reservoir 310. The item 1047 may be aninjection port. The items are selected depending on the circumstances,e.g. if the apparatus is electrically, hydraulically, pneumatically ormechanically operated.

If a non-rechargeable battery is used the energy-transforming device 398may be omitted but the items 307, 309, 310, 315, 322, 325, and 1047 maybe used as suitable, and be connected to the apparatus 10 and sensor 202as suitable. If e.g. the apparatus 10 is hydraulically operated it maye.g. be suitable to use a control unit 315, an injection port 1047, apump 309 and/or a reservoir 310.

In general, any item, or combinations of items, described and suitedtherefore, may be connected to the apparatus 10 via the power supplyline 303. The actual item, or combinations of items, are chosendepending on the circumstances, e.g. if the apparatus 10 iselectrically, hydraulically, pneumatically or mechanically operated.

If e.g. the apparatus 10 is mechanically operated it may be connected toa motor 307 via the power supply line 303 which in this case may be awire or bowden cable. A control unit 315 may be connected to the motor307.

If e.g. the apparatus 10 is electrically operated it may be suitable toconnect it to a source of electrical energy 322 via the power supplyline 303 which in this case may be an electrical conduit. A control unit315 may be connected to the source of electrical energy 322.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 304 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 398 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 304 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 398 may directly power the apparatus withthe second form energy, as the energy-transforming device 398 transformsthe first form energy transmitted by the energy-transmission device 304into the second form energy. The system may further include animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 304 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 304. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 304 may beused to directly power the operation device to create kinetic energy forthe operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 398 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 304 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 398 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 1c illustrates an apparatus comprising two stimulation devices 201,implanted in the sexually responsive tissue of the vulva 205 of thepatient.

FIG. 1d illustrates an apparatus 10 implanted in the sexually responsivetissue of the vulva 205 of the patient. Here the apparatus comprisingthe stimulation device 201 and the stimulation device is inside aprosthesis 203. The prosthesis may be expandable to temporarily achieveenlarged status of the female erectile tissue. The prostheses iscontrolled and energized by the system 300 in the same manner as thestimulation device.

FIG. 1e illustrates the stimulation device 201 implanted so that it canstimulate the clitoris 206 of the patient.

FIG. 1f schematically shows one exemplary embodiment, where an eccentricmechanism is used for achieving vibration or movement of the device. Amotor device 201 a, of the stimulation device 201, said motor device 201a, comprising an outer shell 602, a motor 604, a first motor axis 606,an eccentric element 608 eccentrically mounted to the first motor axis606, a second axis 610 which suitably is supported by a bearing mountedto the outer shell 602. The motor device 1001 a may comprise a gear box611 that transforms the speed of rotation of the motor to a suitablespeed.

FIG. 1g illustrates an electromagnetic device 204 which is one mean ofmaking the stimulation device 201 move.

FIG. 2 illustrates the system 300 of FIG. 1 in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 398 powering the apparatus 10 via powersupply line 303, and the external energy-transmission device 304, Thepatient's skin 305, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 3 shows an embodiment of the invention identical to that of FIG. 2,except that a reversing device in the form of an electric switch 306operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 304 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 398transforms the wireless polarized energy into a polarized current foroperating the electric switch 306. When the polarity of the current isshifted by the implanted energy-transforming device 398 the electricswitch 306 reverses the function performed by the apparatus 10.

FIG. 4 shows an embodiment of the invention identical to that of FIG. 2,except that a motor 307 implanted in the patient for operating theapparatus 10 is provided between the implanted energy-transformingdevice 398 and the apparatus 10. The motor 307 is powered with energyfrom the implanted energy-transforming device 398, as the remote controlof the external energy-transmission device 304 transmits a wirelesssignal to the receiver of the implanted energy-transforming device 398.

FIG. 5 shows an embodiment of the invention identical to that of FIG. 2,except that it also comprises an operation device is in the form of anassembly 308 including a motor/pump unit 309 and a fluid reservoir 310is implanted in the patient. In this case the apparatus 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 309 from the fluid reservoir 310 through a conduit 311 to theapparatus 10 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 309 back from the apparatus 10 to the fluidreservoir 310 to return the apparatus to a starting position. Theimplanted energy-transforming device 398 transforms wireless energy intoa current, for example a polarized current, for powering the motor/pumpunit 309 via an electric power supply line 312.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 398 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 6 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 10, in this case hydraulically operated, and the implantedenergy-transforming device 398, and further comprising a hydraulic fluidreservoir 313, a motor/pump unit 309 and an reversing device in the formof a hydraulic valve shifting device 314, all implanted in the patient.Of course the hydraulic operation could easily be performed by justchanging the pumping direction and the hydraulic valve may therefore beomitted. The remote control may be a device separated from the externalenergy-transmission device or included in the same. The motor of themotor/pump unit 309 is an electric motor. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 304, the implanted energy-transforming device398 powers the motor/pump unit 309 with energy from the energy carriedby the control signal, whereby the motor/pump unit 309 distributeshydraulic fluid between the hydraulic fluid reservoir 313 and theapparatus 10. The remote control of the external energy-transmissiondevice 304 controls the hydraulic valve shifting device 314 to shift thehydraulic fluid flow direction between one direction in which the fluidis pumped by the motor/pump unit 309 from the hydraulic fluid reservoir313 to the apparatus 10 to operate the apparatus, and another oppositedirection in which the fluid is pumped by the motor/pump unit 309 backfrom the apparatus 10 to the hydraulic fluid reservoir 313 to return theapparatus to a starting position.

FIG. 7 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 10, the implanted energy-transforming device 398, an implantedinternal control unit 315 controlled by the wireless remote control ofthe external energy-transmission device 304, an implanted accumulator316 and an implanted capacitor 317. The internal control unit 315arranges storage of electric energy received from the implantedenergy-transforming device 398 in the accumulator 316, which suppliesenergy to the apparatus 10. In response to a control signal from thewireless remote control of the external energy-transmission device 304,the internal control unit 315 either releases electric energy from theaccumulator 316 and transfers the released energy via power lines 318and 319, or directly transfers electric energy from the implantedenergy-transforming device 398 via a power line 320, the capacitor 317,which stabilizes the electric current, a power line 321 and the powerline 319, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possiblephysiological parameter of the patient or any functional parameter ofthe system.

In accordance with an alternative, the capacitor 317 in the embodimentof FIG. 7 may be omitted. In accordance with another alternative, theaccumulator 316 in this embodiment may be omitted.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 2,except that a battery 322 for supplying energy for the operation of theapparatus 10 and an electric switch 323 for switching the operation ofthe apparatus 10 are also implanted in the patient. The electric switch323 may be controlled by the remote control and may also be operated bythe energy supplied by the implanted energy-transforming device 398 toswitch from an off mode, in which the battery 322 is not in use, to anon mode, in which the battery 322 supplies energy for the operation ofthe apparatus 10.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 8,except that an internal control unit 315 controllable by the wirelessremote control of the external energy-transmission device 304 also isimplanted in the patient. In this case, the electric switch 323 isoperated by the energy supplied by the implanted energy-transformingdevice 398 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 315 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 315 to releaseelectric energy from the battery 322 for the operation of the apparatus10.

FIG. 10 shows an embodiment of the invention identical to that of FIG.9, except that an accumulator 316 is substituted for the battery 322 andthe implanted components are interconnected differently. In this case,the accumulator 316 stores energy from the implanted energy-transformingdevice 398. In response to a control signal from the wireless remotecontrol of the external energy-transmission device 304, the internalcontrol unit 315 controls the electric switch 323 to switch from an offmode, in which the accumulator 316 is not in use, to an on mode, inwhich the accumulator 316 supplies energy for the operation of theapparatus 10. The accumulator may be combined with or replaced by acapacitor.

FIG. 11 shows an embodiment of the invention identical to that of FIG.10, except that a battery 322 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 304, the internal control unit 315 controlsthe accumulator 316 to deliver energy for operating the electric switch323 to switch from an off mode, in which the battery 322 is not in use,to an on mode, in which the battery 322 supplies electric energy for theoperation of the apparatus 10.

Alternatively, the electric switch 323 may be operated by energysupplied by the accumulator 316 to switch from an off mode, in which thewireless remote control is prevented from controlling the battery 322 tosupply electric energy and is not in use, to a standby mode, in whichthe wireless remote control is permitted to control the battery 322 tosupply electric energy for the operation of the apparatus 10.

It should be understood that the switch 323 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit. FIG. 12 shows anembodiment of the invention identical to that of FIG. 8, except that amotor 307, a mechanical reversing device in the form of a gear box 324,and an internal control unit 315 for controlling the gear box 324 alsoare implanted in the patient. The internal control unit 315 controls thegear box 324 to reverse the function performed by the apparatus 10(mechanically operated). Even simpler is to switch the direction of themotor electronically. The gear box interpreted in its broadestembodiment may stand for a servo arrangement saving force for theoperation device in favour of longer stroke to act.

FIG. 13 shows an embodiment of the invention identical to that of FIG.19 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 315 is powered by thebattery 322 when the accumulator 316, suitably a capacitor, activatesthe electric switch 323 to switch to an on mode. When the electricswitch 323 is in its on mode the internal control unit 315 is permittedto control the battery 322 to supply, or not supply, energy for theoperation of the apparatus 10.

FIG. 14 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 315,motor or pump unit 309, and the external energy-transmission device 304including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 315, which in turn controls thevarious implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device325, may be implanted in the patient for sensing a physiologicalparameter of the patient. The physiological parameter may be at leastone selected from the group consisting of pressure, volume, diameter,stretching, elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysiological parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 325 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, pressure, volume, diameter, stretch,elongation, extension, movement, bending, elasticity, temperature andflow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 315, or alternatively the external wirelessremote control of the external energy-transmission device 304, maycontrol the apparatus 10 in response to signals from the sensor 325. Atransceiver may be combined with the sensor 325 for sending informationon the sensed physiological parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 315 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit315 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 309 and battery 322 for powering themotor/pump unit 309 are implanted, information related to the chargingof the battery 322 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 15 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body. The system 300 comprises abattery 322 connected to the apparatus 10 via a subcutaneous electricswitch 326. Thus, the regulation of the apparatus 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 16 shows an alternative embodiment, wherein the system 300comprises a hydraulic fluid reservoir 313 hydraulically connected to theapparatus. Non-invasive regulation is performed by manually pressing thehydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 17 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysiological parameter of the patient, in order to supply an accurateamount of energy to an implanted internal energy receiver 398 connectedto implanted energy consuming components of the apparatus 10. Such anenergy receiver 398 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 304 a located outside thepatient and is received by the internal energy receiver 398 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 10. An energy balance is determined between the energyreceived by the internal energy receiver 398 and the energy used for theapparatus 10, and the transmission of wireless energy is then controlledbased on the determined energy balance. The energy balance thus providesan accurate indication of the correct amount of energy needed, which issufficient to operate the apparatus 10 properly, but without causingundue temperature rise.

In FIG. 17 the patient's skin is indicated by a vertical line 305. Here,the energy receiver comprises an energy-transforming device 398 locatedinside the patient, preferably just beneath the patient's skin 305.Generally speaking, the implanted energy-transforming device 398 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 398 is adapted to receive wireless energy Etransmitted from the external energy source 304 a provided in anexternal energy-transmission device 304 located outside the patient'sskin 305 in the vicinity of the implanted energy-transforming device398.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 304 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 398. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 304 b that controls the externalenergy source 304 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 315 connected to the apparatus 10.

The internal control unit 315 may thus be arranged to receive variousmeasurements obtained by suitable sensors or the like, not shown,measuring certain characteristics of the apparatus 10, somehowreflecting the required amount of energy needed for proper operation ofthe apparatus 10. Moreover, the current condition of the patient mayalso be detected by means of suitable measuring devices or sensors, inorder to provide parameters reflecting the patient's condition. Hence,such characteristics and/or parameters may be related to the currentstate of the apparatus 10, such as power consumption, operational modeand temperature, as well as the patient's condition reflected byparameters such as; body temperature, blood pressure, heartbeats andbreathing. Other kinds of physiological parameters of the patient andfunctional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 316 mayoptionally be connected to the implanted energy-transforming device 398for accumulating received energy for later use by the apparatus 10.Alternatively or additionally, characteristics of such an accumulator,also reflecting the required amount of energy, may be measured as well.The accumulator may be replaced by a rechargeable battery, and themeasured characteristics may be related to the current state of thebattery, any electrical parameter such as energy consumption voltage,temperature, etc. In order to provide sufficient voltage and current tothe apparatus 10, and also to avoid excessive heating, it is clearlyunderstood that the battery should be charged optimally by receiving acorrect amount of energy from the implanted energy-transforming device398, i.e. not too little or too much.

The accumulator may also be a capacitor with correspondingcharacteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 315. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 315 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit315 is further connected to an internal signal transmitter 327, arrangedto transmit a control signal reflecting the determined required amountof energy, to an external signal receiver 304 c connected to theexternal control unit 304 b. The amount of energy transmitted from theexternal energy source 304 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 304 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 304 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 304 b, thus integrating the above-describedfunction of the internal control unit 315 in the external control unit304 b. In that case, the internal control unit 315 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 327 which sends the measurements over to the external signalreceiver 304 c and the external control unit 304 b. The energy balanceand the currently required amount of energy can then be determined bythe external control unit 304 b based on those sensor measurements.

Hence, the present solution according to the arrangement of FIG. 17employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 327 and the externalsignal receiver 304 c may be integrated in the implantedenergy-transforming device 398 and the external energy source 304 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 17, the switch 328is either separate and controlled by the internal control unit 315, orintegrated in the internal control unit 315. It should be understoodthat the switch 328 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 17 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 315 of the determination device.A control signal reflecting the required amount of energy is alsocreated by the internal control unit 315, and the control signal istransmitted from the internal signal transmitter 327 to the externalsignal receiver 304 c. Alternatively, the energy balance can bedetermined by the external control unit 304 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 304 a can then be regulated bythe external control unit 304 b, based on the determined energy balance,e.g. in response to the received control signal. This process may berepeated intermittently at certain intervals during ongoing energytransfer, or may be executed on a more or less continuous basis duringthe energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 304 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics. This system may also be used to obtain informationabout the coupling factors between the coils in a TET system even tocalibrate the system both to find an optimal place for the external coilin relation to the internal coil and to optimize energy transfer. Simplycomparing in this case the amount of energy transferred with the amountof energy received. For example if the external coil is moved thecoupling factor may vary and correctly displayed movements could causethe external coil to find the optimal place for energy transfer.Preferably, the external coil is adapted to calibrate the amount oftransferred energy to achieve the feedback information in thedetermination device, before the coupling factor is maximized.

This coupling factors information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorsbetween the first and second coils. The transmitted energy may beregulated depending on the obtained coupling factor.

With reference to FIG. 18, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 18,wherein an external switch 326 is interconnected between the externalenergy source 304 a and an operation device, such as an electric motor307 operating the apparatus 10. An external control unit 304 b controlsthe operation of the external switch 326 to effect proper operation ofthe apparatus 10.

FIG. 19 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.17, an internal energy receiver 397 receives wireless energy E from anexternal energy source 304 a which is controlled by a transmissioncontrol unit 304 b. The internal energy receiver 397 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 397 may further comprise a constant currentcircuit, indicated as a dashed box “constant C” in the figure, forsupplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 397. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 c for stabilizing the energy supplied fromthe internal energy receiver 397. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 397 may further beaccumulated and/or stabilized by a separate energy stabilizing unit 10 clocated outside the apparatus 10, before being consumed and/or stored bythe apparatus 10. Alternatively, the energy stabilizing unit 10 c may beintegrated in the internal energy receiver 397. In either case, theenergy stabilizing unit 10 c may comprise a constant voltage circuitand/or a constant current circuit.

It should be noted that FIG. 17 and FIG. 19 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 20 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such change takes place. If the amount of receivedenergy is lower than the energy used by the implant, more energy istransferred and thus charged into the energy source. The output signalfrom the circuit is typically feed to an A/D converter and convertedinto a digital format. The digital information can then be sent to theexternal energy-transmission device allowing it to adjust the level ofthe transmitted energy. Another possibility is to have a completelyanalog system that uses comparators comparing the energy balance levelwith certain maximum and minimum thresholds sending information toexternal energy-transmission device if the balance drifts out of themax/min window.

The schematic FIG. 20 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 3; the transmitting parts ofthe system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 20and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 20 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 306 of FIG. 3 could be incorporated in any of theembodiments of FIGS. 6-12, the hydraulic valve shifting device 314 ofFIG. 6 could be incorporated in the embodiment of FIG. 5, and the gearbox 324 could be incorporated in the embodiment of FIG. 4. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 17, 19 and 20identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physiological parameters of the medical deviceand/or physiological parameters of the patient are determined, theenergy may be transmitted for consumption and storage according to atransmission rate per time unit which is determined based on saidparameters. The total amount of transmitted energy may also bedetermined based on said parameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   A primary coil in the external energy source adapted to transmit the    wireless energy inductively to a secondary coil in the internal    energy receiver.-   The determination device is adapted to detect a change in the energy    balance, and the control device controls the transmission of    wireless energy based on the detected energy balance change-   The determination device is adapted to detect a difference between    energy received by the internal energy receiver and energy used for    the implantable energy consuming components of the apparatus, and    the control device controls the transmission of wireless energy    based on the detected energy difference.-   The control device controls the external energy-transmission device    to decrease the amount of transmitted wireless energy if the    detected energy balance change implies that the energy balance is    increasing, or vice versa, wherein the decrease/increase of energy    transmission corresponds to a detected change rate.-   The control device controls the external energy-transmission device    to decrease the amount of transmitted wireless energy if the    detected energy difference implies that the received energy is    greater than the used energy, or vice versa, wherein the    decrease/increase of energy transmission corresponds to the    magnitude of said detected energy difference.-   The energy used for the apparatus is consumed to operate the    apparatus, and/or stored in at least one energy storage device of    the apparatus.-   Where electrical and/or physiological parameters of the apparatus    and/or physiological parameters of the patient are determined, the    energy-transmission device transmits the energy for consumption and    storage according to a transmission rate per time unit which is    determined by the determination device based on said parameters. The    determination device also determines the total amount of transmitted    energy based on said parameters.-   When a difference is detected between the total amount of energy    received by the internal energy receiver and the total amount of    consumed and/or stored energy, and the detected difference is    related to the integral over time of at least one measured    electrical parameter related to the energy balance, the    determination device determines the integral for a monitored voltage    and/or current related to the energy balance.-   When the derivative is determined over time of a measured electrical    parameter related to the amount of consumed and/or stored energy,    the determination device determines the derivative for a monitored    voltage and/or current related to the energy balance.-   The energy-transmission device comprises a coil placed externally to    the human body, and an electric circuit is provided to power the    external coil with electrical pulses to transmit the wireless    energy. The electrical pulses have leading and trailing edges, and    the electric circuit is adapted to vary first time intervals between    successive leading and trailing edges and/or second time intervals    between successive trailing and leading edges of the electrical    pulses to vary the power of the transmitted wireless energy. As a    result, the energy receiver receiving the transmitted wireless    energy has a varied power.-   The electric circuit is adapted to deliver the electrical pulses to    remain unchanged except varying the first and/or second time    intervals.-   The electric circuit has a time constant and is adapted to vary the    first and second time intervals only in the range of the first time    constant, so that when the lengths of the first and/or second time    intervals are varied, the transmitted power over the coil is varied.-   The electric circuit is adapted to deliver the electrical pulses to    be varied by only varying the lengths of first time intervals    between successive leading and trailing edges of the electrical    pulses.-   The electric circuit is adapted to supplying a train of two or more    electrical pulses in a row, said train having a first electrical    pulse at the start of the pulse train and having a second electrical    pulse at the end of the pulse train, and-   the lengths of the second time intervals between successive trailing    edge of the second electrical pulse in a first pulse train and    leading edge of the first electrical pulse of a second pulse train    are varied by the first electronic circuit.-   The electric circuit is adapted to provide the electrical pulses as    pulses having a substantially constant height and/or amplitude    and/or intensity and/or voltage and/or current and/or frequency.-   The electric circuit has a time constant, and is adapted to vary the    first and second time intervals only in the range of the first time    constant, so that when the lengths of the first and/or second time    intervals are varied, the transmitted power over the first coil are    varied.-   The electric circuit is adapted to provide the electrical pulses    varying the lengths of the first and/or the second time intervals    only within a range that includes the first time constant or that is    located relatively close to the first time constant, compared to the    magnitude of the first time constant.

FIGS. 21-24 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 21 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 313,a one way pump 309 and an alternate valve 314.

FIG. 22 shows the apparatus 10 and a fluid reservoir 313. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 23 shows the apparatus 10, a two way pump 309 and the regulationreservoir 313.

FIG. 24 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 313 and a servo reservoir 350. Theservo reservoir 350 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 354. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 352 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 350.

The servo reservoir 350 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 25a-c . InFIG. 25a , a flexible subcutaneous regulation reservoir 313 is shownconnected to a bulge shaped servo reservoir 350 by means of a conduit311. This bellow shaped servo reservoir 350 is comprised in a flexibleapparatus 10. In the state shown in FIG. 25a , the servo reservoir 350contains a minimum of fluid and most fluid is found in the regulationreservoir 313. Due to the mechanical interconnection between the servoreservoir 350 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 25b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 313 so thatfluid contained therein is brought to flow through the conduit 311 andinto the servo reservoir 350, which, thanks to its bellow shape, expandslongitudinally. This expansion in turn expands the apparatus 10 so thatit occupies its maximum volume.

The regulation reservoir 313 is preferably provided with means 313 a forkeeping its shape after compression. This means, which is schematicallyshown in the figure, will thus keep the apparatus 10 in a stretchedposition also when the user releases the regulation reservoir. In thisway, the regulation reservoir essentially operates as an on/off switchfor the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 26 and 27 a-c. The block diagramshown in FIG. 26 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir313 and a servo reservoir 350. The servo reservoir 350 mechanicallycontrols a larger adjustable reservoir 352 via a mechanicalinterconnection 354. An implanted apparatus 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 352 by supply of hydraulic fluid from the largeradjustable reservoir 352 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 27a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 313 is in fluid connection with a bellow shaped servoreservoir 350 by means of a conduit 311. In the first closed system 313,311, 350 shown in FIG. 27a , the servo reservoir 350 contains a minimumof fluid and most fluid is found in the regulation reservoir 313.

The servo reservoir 350 is mechanically connected to a larger adjustablereservoir 352, in this example also having a bellow shape but with alarger diameter than the servo reservoir 350. The larger adjustablereservoir 352 is in fluid connection with the apparatus 10. This meansthat when a user pushes the regulation reservoir 313, thereby displacingfluid from the regulation reservoir 313 to the servo reservoir 350, theexpansion of the servo reservoir 350 will displace a larger volume offluid from the larger adjustable reservoir 352 to the apparatus 10. Inother words, in this reversed servo, a small volume in the regulationreservoir is compressed with a higher force and this creates a movementof a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.25a-c , the regulation reservoir 313 is preferably provided with means313 a (FIG. 27c ) for keeping its shape after compression. This means,which is schematically shown in the figure, will thus keep the apparatus10 in a stretched position also when the user releases the regulationreservoir. In this way, the regulation reservoir essentially operates asan on/off switch for the system.

Other features and uses of the invention and their associated advantageswill be evident to a person skilled in the art upon reading thedescription.

It is to be understood that this invention is not limited to theparticular embodiments shown here. The scope of the present invention islimited only by the appended claims and equivalents thereof.

The invention claimed is:
 1. An apparatus for implantation in a sexuallyresponsive tissue of a vulva of a patient, the apparatus comprising atleast one expandable prosthesis configured to temporarily achieveenlarged status of a female erectile tissue and a stimulation device forcreating vibrations placed inside said expandable prosthesis, whereinthe said expandable prosthesis defines an enclosed volume, thestimulation device being provided within said enclosed volume.
 2. Theapparatus according to claim 1, wherein the expandable prosthesis isadapted to be expanded by hydraulic fluid.
 3. The apparatus according toclaim 1, wherein the stimulation device comprises an eccentric mechanismcausing movement of the hydraulic fluid.
 4. The apparatus according toclaim 1, further comprising at least one reservoir in fluid connectionwith the expandable prosthesis.
 5. The apparatus according to claim 1,further comprising at least one switch implantable in the patient. 6.The apparatus according to claim 1, further comprising a wireless remotecontrol.
 7. The apparatus according to claim 1, further comprising animplantable hydraulic reservoir, hydraulically connected to theapparatus, and adapted to be regulated by manually pressing thehydraulic reservoir.
 8. The apparatus according to claim 1, wherein theapparatus is adapted to be energized non-invasively by at least one of;an implanted internal energy source, and non-invasively and wirelesslyby an energy transmission device from outside the patient's body sendingwireless energy to an internal energy receiver.
 9. The apparatusaccording to claim 1, comprising a sensor and/or a measuring devicesensing or measuring at least one physical parameter of the patient. 10.The apparatus according to claim 1, comprising a sensor and/or ameasuring device sensing or measuring at least one functional parameterrelated to the apparatus.
 11. The apparatus according to claim 1,further comprising an implantable internal control unit and a feedbackdevice for sending feedback information from inside the patient's bodyto the outside of the patient's body.
 12. The apparatus according toclaim 1, where the stimulating device is adapted to create hydraulicmovement with an amplitude from 0.01 to 30 mm.
 13. The apparatusaccording to claim 1, further comprising a control device for manuallycontrolling the at least one stimulating device from outside thepatient's body.
 14. The apparatus according to claim 1, furthercomprising a control device for controlling the intensity of thestimulation device.
 15. The apparatus according to claim 1, comprising acontrol device for independently controlling amplitude and frequency ofthe movement.
 16. The apparatus according to claim 1, wherein thestimulation device comprises an eccentric mechanism.
 17. The apparatusaccording to claim 1, wherein the stimulation device comprises anelectromagnetic mechanism.